# FDA 483 - The Mentholatum Company - March 23, 2026

Source: https://www.keypedia.com/records/483/the-mentholatum-company/80c0f27c-1eb1-43ea-8f41-eb180e1ac4f5

> FDA 483 for The Mentholatum Company on March 23, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: The Mentholatum Company
- Inspection Date: 2026-03-23
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: The Mentholatum Company in Orchard Park, NY, received a Form 483 with four observations following an FDA inspection. The firm demonstrated significant deficiencies in its out-of-specification (OOS) investigation practices, often failing to determine root causes and releasing products based on retest results without proper justification. Additionally, issues were noted in laboratory record-keeping, the unscientific alteration of batch release specifications, and inadequate Annual Product Review procedures, indicating systemic quality control failures.

## Related Documents

- [483 - 2021-06-17](https://www.keypedia.com/records/483/the-mentholatum-company/fd2a2e74-28ba-405b-8c31-9280b8195291)

## Related Officers

- [Lauren H. Augustyniak](https://www.keypedia.com/people/lauren-h-augustyniak/bde81fac-921f-494b-969b-38770fceda7e)

Company: https://www.keypedia.com/companies/the-mentholatum-company/b6fe9a36-3f40-411d-82b1-1c00b610492f

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961